Swedish biotech company Cyxone has received approval from the Medical Product Agency (Office for Registration of Medicinal Products, Medical devices and Biocides) and the Central Ethics Committee in Poland to start a clinical phase 2b study with its drug candidate Rabeximod, which is being developed as a treatment for rheumatoid arthritis (RA).
“The approval is a very important milestone for us. Cyxone has now finally the possibility to initiate the greatest and foremost value-building activity ever in the company’s history. Receiving this green light from Poland, which will be the most important country for the upcoming study, is a great achievement. We are now looking forward to continuing working towards our goal to be able to offer a safe and user-friendly treatment which also contributes to improved quality of life for the patient,” said Carl-Magnus Högerkorp, acting CEO, Cyxone.
The study is a multicenter, randomized, double-blinded, placebo-controlled clinical study where patients with moderate to severe RA, who have previously been treated with methotrexate with inadequate response, will be treated with Rabeximod for 24 weeks. The aim of the study is to confirm the therapeutic efficacy of Rabeximod in this patient population, as well as to expand the safety data documentation.
Cyxone’s Rabeximod is a well-tolerated, orally available phase 2 candidate drug with a unique mechanism of action. Rabeximod selectively targets the inflammatory macrophage, a type of white blood cell that is the central orchestrator of the inflammatory process that causes tissue destruction and clinical symptoms in RA.
Combined with the convenience of oral administration and a beneficial tolerability profile, this opens up treatment in the early as well as later stages of the disease. It is believed to be particularly effective at onset and relapses of RA, with good potential to prevent joint destruction and progression of the disease.
Cyxone AB develops disease modifying therapies for diseases such as rheumatoid arthritis and multiple sclerosis. Rabeximod is a phase 2 candidate drug being evaluated for the management of rheumatoid arthritis. T20K is a phase 1 candidate drug for treatment of multiple sclerosis.